510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Acufex Microsurgical, Inc.

Mchenry, IL, US

Acufex Microsurgical, Inc. appears in FDA device records in Mchenry, IL. FDA records list 78 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
78
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 78

FDA records hold 78 510(k) clearances for Acufex Microsurgical, Inc. between 1980 and 1996. The busiest year on record is 1994, with 25. The most recent is 1996, with 4.

Clearances by year, as a table
510(k) clearance decisions for Acufex Microsurgical, Inc., by decision year
YearClearances
19802
19821
19835
19845
19852
19883
19893
19904
19911
19925
19939
199425
19959
19964
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K961555ACUFEX TAG BIOABSORBABLE ANCHORSJDRSubstantially Equivalent
K961853PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSERHRXSubstantially Equivalent
K954246ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREWHWCSubstantially Equivalent for Some Indications
K952535ACUFEX ENDOBUTTON TAPEGATSubstantially Equivalent for Some Indications
K953276ACUFEX TAG DELIVERY SYSTEMJDRSubstantially Equivalent
K953459ACUFEX TAG ANCHORMBISubstantially Equivalent
K941740ACUFEX ROTATOR CUFF FIXATION BUTTONKGSSubstantially Equivalent
K944500ACUFEX PATELLAR BONE BLOCK SIZERHRXSubstantially Equivalent
K951859ACUFEX ENDOBUTTON PACKHRXSubstantially Equivalent
K946346ACUFEX TAG(R) BIOABSORBABLE ANCHORSJDRSubstantially Equivalent
K941709ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMSHRXSubstantially Equivalent
K943548BIOABSORBABLE INTERFERENCE SCREWJDRSubstantially Equivalent
K934867ACUFEX TAG ANCHORJDRSubstantially Equivalent
K942442ACUFEX T-FIX DELIVERY SYSTEMMIASubstantially Equivalent
K942846ACUFEX(R) ENDO-FEMORAL AIMERHRXSubstantially Equivalent
K942834ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULAHRXSubstantially Equivalent
K942574GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDERGCJSubstantially Equivalent
K942079MANUAL SURGICAL INSTRUMENTSHRXSubstantially Equivalent
K940290ACUFEX ACL SHEATH FOR INTERFERENCE SCREWSHRXSubstantially Equivalent
K933948ACUFEX ENDOBUTTON SYSTEMMAISubstantially Equivalent
K932090ACUFEX DISPOSABLE MENISCAL CANNULAHRXSubstantially Equivalent
K931836ACUFEX SMOOTH AND THREADED PINSHTYSubstantially Equivalent
K931519ACUFEX SURETACJDRSubstantially Equivalent
K941364ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMSHRXSubstantially Equivalent
K940985ACUFEX(R) ARTHROPLASTY INSTRUMENTSHRXSubstantially Equivalent
K940981ACUFEX LINEAR/ROTARY INSTRUMENTSHRXSubstantially Equivalent
K940481ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEMHRXSubstantially Equivalent
K940623ACUFEX SURETAC IXC SYSTEMSHRXSubstantially Equivalent
K940506ACUFEX ARTHROSCOPIC SUTURE CUTTERHRXSubstantially Equivalent
K940241ACUFEX VIDEO SYSTEMGCJSubstantially Equivalent
K940480ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICEHTJSubstantially Equivalent
K934181ACUFEX ADJUSTABLE-LENGTH CANNULAHRXSubstantially Equivalent
K932460ACUFEX MENISCAL RASPSHRXSubstantially Equivalent
K932718ACUFEX METAL ACL CANNULAHRXSubstantially Equivalent
K934270ACUFEX ARTHROSCOPEHRXSubstantially Equivalent
K933921ACUFLEX DISPOSABLE KNIVESHTSSubstantially Equivalent
K931621ACUFEX PRO-PAC AND ISO-PACHRXSubstantially Equivalent
K931837ACUFEX STERILE DRILLSHWESubstantially Equivalent
K930538ACUFEX SURETAC(R) PACJDRSubstantially Equivalent
K921481INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIRHWCSubstantially Equivalent
K911293ACUFEX(R) TAG(TM)JDRSubstantially Equivalent
K922766ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATIONHTYUnknown
K920620FLUORO-SHIELD RADIATION REDUCTION GLOVESLZCSubstantially Equivalent
K926036ACUFEX SUTURE RETRIEVERGAESubstantially Equivalent
K925573ACUFEX T-BARHRXSubstantially Equivalent
K923381SOFT TISSUE EXPANDERHWQSubstantially Equivalent
K920621ACUFEX PASSING PINS AND SURGICAL WIREHWQSubstantially Equivalent
K925335ACUFEX INTRA ARTICULAR MEASURING DEVICEHTJSubstantially Equivalent
K922559ACUFEX ENDOFIX BUTTONEBGSubstantially Equivalent
K924514ACUFEX FIXATION POSTHWCSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain